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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`LIQUIDIA TECHNOLOGIES, INC.,
`
`Petitioner
`
`v.
`
`UNITED THERAPEUTICS CORPORATION,
`
`Patent Owner
`
`
`
`
`Inter Partes Review No. IPR2020-00770
`U.S. Patent No. 9,604,901
`
`
`JOINT PAPER CONCERNING PETITIONER’S REQUEST TO STRIKE
`PORTIONS OF PATENT OWNER’S PAPER NOS. 12 AND 25 AND
`EXHIBITS 2002 AND 2025
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`I.
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`TABLE OF CONTENTS
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`B.
`
`Page
`INTRODUCTION AND REQUESTED RELIEF ..................................... 1
`A.
`Issue #1: Whether Claim 1 Requires No Isolation Between
`Method Steps (B) and (C) .................................................................... 1
`Issue #2: Whether Claims 6 and 7 Require Actual Storage ................. 2
`1.
`Petitioner’s Narrative: UTC’s Inconsistent Positions
`Concerning “Storage” of the Treprostinil Salt Prior to
`Use .............................................................................................. 2
`Patent Owner’s Narrative Regarding the “Storage”
`Limitation of Claims 6 and 7 ..................................................... 5
`Chart of Portions of Patent Owner’s Submissions
`Regarding “Storage” that Should be Struck .............................. 8
`
`2.
`
`3.
`
`i
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`
`
`I.
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`INTRODUCTION AND REQUESTED RELIEF
`
`Pursuant to the Board’s Order of May 3, 2021, the parties file this joint paper
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`addressing the portions of Patent Owner’s Response (Paper No. 12), Sur-Reply
`
`(Paper No. 25), and Declarations of Dr. Pinal (EX2002, EX2025) that Petitioner
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`believes should be struck.
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`A.
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`Issue #1: Whether Claim 1 Requires No Isolation Between Method
`Steps (B) and (C)
`
`Attached as Exhibits 1043 to 1046 are highlighted copies of the Patent
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`Owner’s Response, Sur-Reply, Exhibit 2002, and Exhibit 2025, identifying in
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`yellow the portions by page and line number or paragraph number that Petitioner
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`believes should be stricken. Portions identified with strikethrough and in black
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`indicate statements the parties jointly agree should be stricken.
`
`Paper/Exhibit
`Patent Owner
`Response (Paper
`No. 12)
`
`Patent Owner Identification
`of Passages to be Stricken
` 11:10-14
` 15:12-13
` 25:7-8
` 29:5-6, 16-17
` 34:11-17
` 53:9-12
` 56:15-16, 18
` 58:14
` 59:7
` 62:12-13
`
`Petitioner Identification
`of Passages to be Stricken
` 5:13-15
` 5:17-6:8
` 11:5-14
` 15:12-16:5
` Footnote 1
` 19:8-20:18
` 25:1-3
` 29:3-6
` 29:16-34:18
` 51:10-14
` 53:9-12
` 56:14-60:16
` 61:16-64:17
` 66:19-67:13
`1
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`
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`
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`Ex. 2002
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`Ex. 2025
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`Patent Owner’s
`Sur-Reply (Paper
`No. 25)
`
`B.
`
`None
`
`None
`
`None
`
` ¶¶ 135-140
` ¶ 170
` ¶¶ 274-277
` ¶¶ 294-295
` ¶ 304
` ¶ 305
` ¶ 90
` ¶ 91
` ¶ 95
` ¶¶ 156-160
` ¶ 256
` ¶ 258
` ¶ 291
` 4:8-9
` 17:18-18:5
` 19:12
` 22:10-16
` 22:14-16
` 23:1-24:2
` Footnote 3
`Issue #2: Whether Claims 6 and 7 Require Actual Storage
`
`1.
`
`Petitioner’s Narrative: UTC’s Inconsistent Positions
`Concerning “Storage” of the Treprostinil Salt Prior to Use
`
`Claim 6, and its dependent claim 7, recite: “storing a pharmaceutical batch of
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`a salt of treprostinil as claimed in claim 1 at ambient temperature, and preparing a
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`pharmaceutical product from the pharmaceutical batch after storage.” EX1001,
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`18:12-20. UTC argued that the claims require actual storage of the “salt of
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`treprostinil” (evidenced by storage stability data) prior to using the salt to make the
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`claimed pharmaceutical product and that Phares (EX1008) did not “teach or suggest
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`the ‘storing’/‘storage’ limitation in these claims,” because it “provides no stability
`2
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`
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`data.” POR, 11-12, 37-38, 50-52, 65; EX2002, ¶¶222, 229-230, 235-236, 251;
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`EX2025, ¶¶91, 204, 211-212, 217-218, 230, 283-285. UTC also included storage-
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`specific objective indicia of nonobviousness, arguing that “neither Phares nor
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`Moriarty provides any indication of . . . whether refrigerating or other measures
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`would be necessary to provide stability in a batch form.” POR, 68-69. UTC
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`continued to make this argument in its Sur-Reply, specifically stating “Phares offers
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`no guidance about treprostinil or a salt thereof as a pharmaceutical batch to be stored
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`and used for later making finished dosage forms. . . . Phares similarly provides no
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`storage stability data for treprostinil diethanolamine[.]” Sur-Reply, 181; see also
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`id., 11-13 (“storage/storing” limitation requiring actual storage); 24-25 (relying on
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`storage as objective indicia). UTC, thus, interprets claims 6 and 7 to require actual
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`storage of the “salt of treprostinil” prior to use.2
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`UTC’s expert in the parallel district court proceeding, Dr. Ruffolo, opined that
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`in the ʼ901 patent, actual storage was not required. Specifically, Dr. Ruffolo equated
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`the “storage” limitation in claim 6 of the ʼ901 patent with the “storage” limitation in
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`claims 6 and 8 of UTC’s U.S. Patent No. 9,593,066 and provided an identical claim
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`
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`1 All emphasis is added unless otherwise noted.
`2 Whether actual storage is required or not, clams 6 and 7 are invalid for the reasons
`presented in the Petitioner’s Petition and Reply. See Paper No. 1, 43-45, 67-70;
`Paper No. 15, 6-8, 18-21, 26.
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`
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`3
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`
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`construction for the term across both patents. EX2033, ¶ 7. When asked about the
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`“preparing a pharmaceutical product from the treprostinil [salt] after storage” in
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`claim 8 of the ʼ066 patent, Dr. Ruffolo testified that actual storage of treprostinil salt
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`was not required. EX2034, 130:12-132:4. Dr. Ruffolo was then asked about the
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`same limitation in claim 6 of the ʼ901 patent. See id. at 132:15-136:11. When
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`specifically asked “Does Claim 6 [of the ʼ901 patent] require that the pharmaceutical
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`product must be made after storage of the pharmaceutical batch of treprostinil, salt
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`of treprostinil?,” he answered “No.” Id. at 136:7-11. Accordingly, Dr. Ruffolo has
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`opined that claim 6 (and thus claim 7) does not require actual storage of the
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`treprostinil salt prior to use, which conflicts with UTC’s position here.
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`Contrary to UTC’s position below, Dr. Ruffolo did not make an “error”
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`regarding the scope of “comprising.” When explaining why UTC’s “no isolation”
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`statements were incorrect, he applied the definition of “comprising” from the
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`specification (id., 70:17-71:16), reviewed the claim language and the specification’s
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`statement that treprostinil salt “can be” synthesized “without isolation” from the
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`specification. Id., 238:16-239:18, 246:21-247:21, 250:22-252:18. With respect to
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`his opinion that the claims do not require actual storage, Dr. Ruffolo again relied on
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`the definition of the term “comprising” from the specification, the claim language,
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`and the specification’s statement that crude treprostinil “can be” stored. Id., 130:7-
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`133:21. Dr. Ruffolo applied the same definition and rationale for “isolation” and
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`4
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`
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`“storage.” Thus, if UTC is striking its statements regarding “no isolation” based on
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`Dr. Ruffolo’s opinion, UTC’s “actual storage” arguments should similarly be struck
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`based on Dr. Ruffolo’s opinion.
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`2.
`
`Patent Owner’s Narrative Regarding
`Limitation of Claims 6 and 7
`
`the “Storage”
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`Liquidia is incorrect regarding Dr. Ruffolo’s testimony. In the district court
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`litigation, Dr. Ruffolo was tasked with construing the claim terms “stored,”
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`“storing,” and “storage,” and provided his opinions on what those terms mean in the
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`context of the claims. Liquidia’s Answering claim construction brief in the district
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`court never argued that the “comprising” term was relevant to the construction of
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`“storage” and Dr. Ruffolo was not asked to consider, until Liquidia asked him at his
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`deposition, the legal question of what “comprising” requires by way of storage.
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`Liquidia’s motion to strike improperly attempts to exploit Dr. Ruffolo’s
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`misstatement concerning a question of law from a different context in a separate
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`proceeding. This desperate attack should be rejected. The Board has already
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`considered and properly construed the “storage” terms in light of the claims,
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`specification, and prosecution history. Dr. Ruffolo’s sworn declaration provides
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`further POSA support for the “storage” construction adopted by the Board.
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`Claim 6 is clear. It recites a “method of preparing a pharmaceutical product
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`from a pharmaceutical batch as claimed in claim 1, comprising storing a
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`pharmaceutical batch of a salt of treprostinil as claimed in claim 1 at ambient
`5
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`
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`temperature, and preparing a pharmaceutical product from the pharmaceutical batch
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`after storage.” EX1001, 18:12-18.
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`Liquidia offers a partial quote from Dr. Ruffolo’s testimony, but when
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`considered in a more complete manner, it is clear that Dr. Ruffolo is simply ascribing
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`a meaning to “comprising” that is not proper. Specifically, Dr. Ruffolo correctly
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`indicates that he understands that “comprising means not limited to,” but he takes
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`the meaning a step further by equating “comprising” as “permissive” (i.e., optional)
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`when considering the storage limitation.
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`This is not the black letter meaning of “comprising” in patent law or the
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`explicit meaning assigned in the patent. Liquidia knows as much, but is attempting
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`to take an answer from a fact expert during a sprawling deposition regarding the
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`legal definition of “comprising” and expand this statement to effectively eliminate
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`the claims for which Liquidia failed to meet its initial burden in its Petition (claims
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`6 and 7) from this proceeding. This effort to use a misunderstanding about a legal
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`concept of claim interpretation relating to the word “comprising” in order to remove
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`an express limitation of the claim should not be entertained by the Board.
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`A more complete quote from Dr. Ruffolo’s testimony shows his error in
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`understanding “comprising” as synonymous with “permissive” (i.e., optional) when
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`considering the storage limitation:
`
`Q. Yes, Claim 6 of the ’901 Patent.
`A. Yes, I see that.
`
`6
`
`
`
`
`
`Q. Okay.
`And in your opinion, does Claim 6 require actual storage
`of the pharmaceutical batch of the salt of treprostinil?
`MR. WARD: Objection to form.
`THE WITNESS: Again, I see the word “comprising” there
`and that’s defining the patent as not being limited to. I
`don’t see anything prohibiting not being stored. And the
`specification, likewise, I think on the previous page -- or
`no, on the same page, says that it -- it can be, so that looks
`permissive to me as well.
`. . .
`Q. Does Claim 6 require that the pharmaceutical product
`must be made after storage of the pharmaceutical batch of
`treprostinil, salt of treprostinil?
`A. No.
`MR. WARD: Objection to form.
`BY MR. DAVIES:
`Q. Why not?
`A. Because, again, it can be. There’s nothing preventing
`it. The specification says it can be. And also, while it says
`comprising, and again, according to the definition in the
`patent, comprising means not limited to. And so these all
`appear like permissive language.
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`EX2034, 133:7-21, 136:7-21.
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`Also, according to the ’901 specification, “comprising” means the following:
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`“The expression ‘comprising’ means ‘including but not limited to.’ Thus, other non-
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`mentioned substances, additives, carriers, or steps may be present.” Clearly,
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`“including” is not an optional term, and this definition is consistent with the typical
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`meaning for “comprising.”
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`The Board should see these statements for what they are: a witness who, under
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`cross-examination, erroneously applied “comprising” in a manner that is not in
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`
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`7
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`
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`accordance with the accepted definition of “comprising” and contrary to the stated
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`definition in the ’901 specification. Striking UTC’s arguments and evidence
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`regarding claims 6 and 7 over prima facie erroneous statements in Dr. Ruffolo’s
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`deposition would be an improper use of motion to strike practice.
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`3.
`
`Chart of Portions of Patent Owner’s Submissions Regarding
`“Storage” that Should be Struck
`
`Petitioner identifies the following passages to be stricken, highlighted orange
`
`in Exhibits 1043 to 1046. Patent Owner contends that no passages need to be
`
`stricken.
`
`Patent Owner Response
`(Paper No. 12)
`4:17-5:1
`12:6-9
`15:6-8
`24:14-15
`29:6
`37:15-38:10
`50:7-51:8
`51:18-52:2
`65:2-18
`67:11-12
`68:7-69:4
`
`
`
`
`
`Patent Owner’s Sur-
`Reply (Paper No. 25)
`10:11-11:5
`11:15-13:4
`18:9-19:2
`19:12-13
`20:18-19
`24:13-25:10
`
`Ex. 2002
`
`Ex. 2025
`
`¶¶ 124-126
`¶ 135
`¶¶ 222-224
`¶¶ 229-230
`¶¶ 235-236
`¶ 240
`¶¶ 243-244
`
`¶ 81
`¶ 90
`¶ 91
`¶ 201
`¶¶ 204-206
`¶¶ 210-212
`¶¶ 217-218
`¶ 222
`¶ 276
`¶¶ 283-285
`
`
`
`8
`
`
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`Dated: May 17, 2021
`
`
`Respectfully submitted,
`
`FOLEY & LARDNER LLP
`
`By: /Stephen B. Maebius/
`Stephen B. Maebius
`Reg. No. 35,264
`Counsel for Patent Owner
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`
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`Respectfully submitted,
`
`COOLEY LLP
`
`By: /Ivor R. Elrifi/
`Ivor R. Elrifi
`Reg. No. 39,529
`Counsel for Petitioner
`
`COOLEY LLP
`ATTN: Patent Group
`1299 Pennsylvania Ave., NW, Suite
`Washington, DC 20004
`Tel: (212) 479-6840
`Fax: (212) 479-6275
`
`
`
`
`9
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`I hereby certify, pursuant to 37 C.F.R. Section 42.6, that a complete copy of
`the attached JOINT PAPER CONCERNING PETITIONER’S REQUEST TO
`STRIKE PORTIONS OF PATENT OWNER’S PAPER NOS. 12 AND 25
`AND EXHIBITS 2002 AND 2025 and related documents, are being served via
`electronic mail on the 17th day of May, 2021, upon Patent Owner by serving the
`Patent Owner’s counsel in this proceeding as follows:
`
`
`
`
`
`UTC-901@foley.com
`Stephen B. Maebius (smaebius@foley.com)
`George Quillin (gquillin@foley.com)
`Daniel R. Shelton (dshelton@foley.com)
`FOLEY & LARDNER LLP
`
`Douglas Carsten (dcarsten@mwe.com)
`April E. Weisbruch (aweisbruch@mwe.com)
`Judy Mohr (jmohr@mwe.com)
`MCDERMOTT WILL & EMERY LLP
`
`Richard Torczon (rtorczon@wsgr.com)
`WILSON, SONSINI, GOODRICH & ROSATI
`
`Shaun R. Snader (ssnader@unither.com)
`UNITED THERAPEUTICS CORP.
`
`
`
`DATED: May 17, 2021
`
`
`
`
`
`
`
`
`
`10
`
`/Ivor R. Elrifi/
`Ivor R. Elrifi
`Reg. No. 39,529
`
`COOLEY LLP
`1299 Pennsylvania Ave. NW
`Suite 700
`Washington, D.C. 20004
`Tel: (212) 479-6840
`Fax: (212) 479-6275
`
`
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